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Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD (COSYCONET)

This study is currently recruiting participants.
Verified May 2012 by Philipps University Marburg Medical Center
Sponsor:
Collaborators:
Hannover Medical School
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Claus Vogelmeier, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01245933
First received: November 18, 2010
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to determine the prevalence and severity of extrapulmonary disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and mortality of COPD patients.

Furthermore the investigators evaluate the relationship between systemic inflammation and organ involvement.


Condition
Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Change from baseline in BODE-Score at 18 month's [ Time Frame: at initial visite, after 18 month ] [ Designated as safety issue: No ]
    The BODE-Score comprises BMI, airway obstruction, dyspnoe and exercise capacity and is a good predictor for death in COPD patients. Progression is defined as a change in BODE-score by >=1 point over the observation period.


Secondary Outcome Measures:
  • COPD related mortality [ Time Frame: after 18 month ] [ Designated as safety issue: No ]
  • COPD related hospitalisation [ Time Frame: after 18 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood urine


Estimated Enrollment: 3000
Study Start Date: November 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Chronic diseases and comorbidities have an increasing impact on individual life and health care use, as exemplified in chronic obstructive pulmonary disease (COPD). Currently, independent, comprehensive databases allowing for an integrated view are lacking. The study will for the first time establish a large, comprehensive longitudinal database covering a broad panel of comorbidities an markers of systemic alterations. These data will be of unique value in revealing specific phenotypes of COPD via patterns and risk profiles of comorbidities, enabling a more precise diagnosis and targeting of therapy, and an efficient allocation of resources.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Since the original recruitment strategy was not as successful as expected,the mode of recruitment was extended to other physicians, patients' groups and organisations and advertising to local media. The recruitment is supported by professional measures of communication organized by the coordinating centre Marburg.

Criteria

Inclusion Criteria:

  • aged 40 years and older
  • diagnosis of COPD (GOLD-Criteria)
  • informed consent
  • available for repeated study visits pver 18 months

Exclusion Criteria:

  • having undergone lung surgery (e.g. lung reduction, lung transplant)
  • Moderate or severe exacerbation within the last 4 weeks
  • having a lung tumor
  • Unable to walk or to understand the intention of the project
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245933

Contacts
Contact: Sandra Söhler, Dr. +49 6421 586 4536 soehler@asconet.net
Contact: Inge Kokot +49 6421 586 4536 kokot@asconet.net

Locations
Germany
Kreisklinik Bad Reichenhall, Zentrum für Innere Medizin-Lungenzentrum Recruiting
Bad Reichenhall, Germany, 83435
Contact: Gropper, Dr.         u.gropper@gblmed.de    
Principal Investigator: Rainer Hauck, Prof.            
Ev. Lungenklinik (ELK), Krankenhausbetriebs gGmbH, Pneumologische Klinik Recruiting
Berlin, Germany, 13125
Contact: Andreas Wilke, Dr.            
Principal Investigator: Christian Grohé, Prof.            
BG-Universitätskliniken Bergmannsheil GmbH, Medical Clinic Recruiting
Bochum, Germany, 44789
Contact: Juliane Kronsbein, Dr.         juliane.kronsbein@ruhr-uni-bochum.de    
Principal Investigator: A. Mügge, Prof.            
Forschungszentrum Borstel, Medizinische Klinik Recruiting
Borstel, Germany, 23845
Contact: Herzmann, Dr.         cherzmann@fz-borstel.de    
Principal Investigator: Peter Zabel, Prof.            
Krankenhaus Coswig Recruiting
Coswig, Germany, 01640
Contact: Markus Herden, Dr.         herden@fachkrankenhaus-coswig.de    
Contact: Christophe Ninck-Weber, Dr.         Ninck@fachkrankenhaus-coswig.de    
Principal Investigator: Gert Höffken, Prof. Dr.            
Klinik Donaustauf, Zentrum für Pneumologie Recruiting
Donaustauf, Germany, 93093
Contact: Stefan Blaas, Dr.         stefan.blaas@klinik.uni-regensburg.de    
Principal Investigator: Michael Pfeifer, Prof.            
Klinikum Fürth, Medizinische Klinik I Active, not recruiting
Fürth, Germany, 90766
Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität, Zentrum für Innere Medizin Recruiting
Greifswald, Germany, 17475
Contact: Sven Gläser, Dr.            
Principal Investigator: Ralf Ewert, Prof.            
Krankenhaus Großhansdorf, Pneumologisches Forschungsinstitut Recruiting
Großhansdorf, Germany, 22927
Contact: Henrik Watz, Dr.         h.watz@pulmoresearch.de    
Principal Investigator: Helgo Magnussen, Prof.            
HIT-Hamburger Institut für Therapieforschung GmbH Recruiting
Hamburg, Germany, 20354
Contact: Margret Jandl, Dr.         jandl@hit-forschung.de    
Principal Investigator: Hartmut Timmermann, Dr.            
Medical School Hannover, Dep. of Pneumology Recruiting
Hannover, Germany, 30625
Contact: Tobias Welte, Prof.         welte.tobias@mh-hannover.de    
Principal Investigator: Tobias Welte, Prof.            
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Michael Kreuter, Dr.         michael.kreuter@thoraxklinik-heidelberg.de    
Principal Investigator: Felix Herth, Prof.            
Universitätsklinik Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Celine Weiss, Dr.         celine.weiss@med.uni-heidelberg.de    
Principal Investigator: Hugo A. Katus, Prof.            
University of Saarland Recruiting
Homburg, Germany, 66421
Contact: Sebastian Fähndrich, Dr.         sebastian.faehndrich@uniklinikum-saarland.de    
Principal Investigator: Robert Bals, Prof.            
Fachklinik für Lungenerkrankungen Philippsstiftung ev. Recruiting
Immenhausen, Germany, 34376
Contact: Christine Löffler, Dr.         lini82@gmx.de    
Principal Investigator: Stefan Andreas, Prof.            
Universitiy of Kiel Recruiting
Kiel, Germany, 24105
Contact: Rainer Noth, Dr.         rnoth@1med.uni-kiel.de    
Principal Investigator: Burkhardt Bewig, Prof. Dr.            
Universitätsklinikum Leipzig, Department Innere Medizin Recruiting
Leipzig, Germany, 04103
Contact: Jens Bräunlich, Dr.         jens.braeunlich@medizin.uni-leipzig.de    
Principal Investigator: Hubert Wirtz, Prof.            
Philipps-University Marburg, Medical Center, Dep. of Pneumology Recruiting
Marburg, Germany, 35042
Contact: Claus Vogelmeier, Prof.         claus.vogelmeier@med.uni-marburg.de    
Principal Investigator: Claus Vogelmeier, Prof.            
Ludwig-Maximilians-University, Medizinische Klinik Innenstadt Recruiting
Munic, Germany, 80336
Contact: Stefan Karrasch, Dr.         stefan.karrasch@med.uni-muenchen.de    
Principal Investigator: R M Huber, Prof.            
Klinikum Nürnberg, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie und Schlafmedizin Recruiting
Nürnberg, Germany, 90419
Contact: Manfred Wagner, Dr.         manfred.wagner@klinikum-nuernberg.de    
Principal Investigator: Joachim Ficker, Prof.            
Fachkrankenhaus Kloster Grafschaft Not yet recruiting
Schmallenberg, Germany, 57392
Contact: Olaf Bourgund, Dr.         o.bourgund@fkkg.de    
Contact: Peter Kemper, Dr.         p.kemper@fkkg.de    
Principal Investigator: Dieter Köhler, Prof.            
Klinikum Berchtesgardener Land, Schön Kliniken, Fachzentrum für Pneumologie, Allergologie und Schlafmedizin Recruiting
Schönau am Königssee, Germany, 83471
Contact: Bernd Lamprecht, Dr.         B.LAMPRECHT@SALK.AT    
Principal Investigator: Klaus Kenn, Dr.            
Krankenhaus Bethanien gGmbH Recruiting
Solingen, Germany, 42699
Contact: Christina Priegnitz, Dr.         chistina.priegnitz@klinik-bathanien.de    
Principal Investigator: Winfried Randerath, Prof.            
University of Ulm Recruiting
Ulm, Germany, 89081
Contact: Chriatian Schumann, PD Dr.         christian.schumann@uniklinik-ulm.de    
Contact: Christian Schumann, PD Dr.            
Principal Investigator: Christian Schumann, PD DR.            
Missionsärztliche Klinik GmbH, Innere Medizin Recruiting
Würzburg, Germany, 97067
Contact: Frank Kornitzki            
Principal Investigator: Berthold Jany, Prof.            
Sponsors and Collaborators
Philipps University Marburg Medical Center
Hannover Medical School
Ludwig-Maximilians - University of Munich
Investigators
Study Chair: Claus Vogelmeier, Prof. Philipps University Marburg Medical Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Claus Vogelmeier, Prof. Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01245933     History of Changes
Other Study ID Numbers: 01GI0881
Study First Received: November 18, 2010
Last Updated: May 23, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
COPD
register
comorbidities
systemic inflammation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013